Intrarosa(prasterone)
Intrarosa (prasterone) is a small molecule pharmaceutical. Prasterone was first approved as Intrarosa on 2016-11-16. It is used to treat adrenal insufficiency, dyspareunia, lupus vulgaris, and sexual and gender disorders in the USA. It has been approved in Europe to treat postmenopause.
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Commercial
Trade Name
FDA
EMA
Intrarosa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Prasterone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INTRAROSA | Millicent Pharma | N-208470 RX | 2016-11-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| balance plus cream | unapproved drug other | 2025-06-01 |
| ibuprofen | ANDA | 2014-04-08 |
| intrarosa | New Drug Application | 2025-01-01 |
| prastera | unapproved drug other | 2014-02-25 |
| prastera - ibuprofen | ANDA | 2014-05-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| adrenal insufficiency | — | D000309 | — |
| dyspareunia | — | D004414 | N94.1 |
| sexual and gender disorders | — | D019968 | — |
| lupus vulgaris | EFO_1001023 | D008177 | A18.4 |
Agency Specific
FDA
EMA
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A14: Anabolic agents for systemic use
— A14A: Anabolic steroids
— A14AA: Androstan derivatives
— A14AA07: Prasterone
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03E: Androgens and female sex hormones in combination
— G03EA: Androgens and estrogens
— G03EA03: Prasterone and estrogen
— G03X: Other sex hormones and modulators of the genital system in atc
— G03XX: Other sex hormones and modulators of the genital system in atc
— G03XX01: Prasterone
HCPCS
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Clinical
Clinical Trials
208 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrophic vaginitis | D059268 | EFO_1001271 | — | — | — | 7 | — | — | 7 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | 2 | — | — | 2 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | — | — | 2 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Hot flashes | D019584 | — | — | — | — | 1 | — | — | 1 |
| Dyspareunia | D004414 | — | N94.1 | — | — | 1 | — | — | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Prasterone |
| INN | prasterone |
| Description | Dehydroepiandrosterone is an androstanoid that is androst-5-ene substituted by a beta-hydroxy group at position 3 and an oxo group at position 17. It is a naturally occurring steroid hormone produced by the adrenal glands. It has a role as an androgen, a human metabolite and a mouse metabolite. It is a 17-oxo steroid, an androstanoid and a 3beta-hydroxy-Delta(5)-steroid. |
| Classification | Small molecule |
| Drug class | steroids (androgens, anabolics); antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12CC[C@H]3[C@@H](CC=C4C[C@@H](O)CC[C@@]43C)[C@@H]1CCC2=O |
Identifiers
| PDB | — |
| CAS-ID | 53-43-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL90593 |
| ChEBI ID | 28689 |
| PubChem CID | 5881 |
| DrugBank | DB01708 |
| UNII ID | 459AG36T1B (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Intrarosa – AMAG Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 29,952 documents
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Safety
Black-box Warning
Black-box warning for: Ibuprofen, Prastera, Prastera - ibuprofen
Adverse Events
Top Adverse Reactions
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1,582 adverse events reported
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